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106th CONGRESS
  2d Session
                                S. 3184

To amend the Federal Food, Drug, and Cosmetic Act to require premarket 
consultation and approval with respect to genetically engineered foods, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

            October 11 (legislative day, September 22), 2000

  Mr. Durbin introduced the following bill; which was read twice and 
   referred to the Committee on Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to require premarket 
consultation and approval with respect to genetically engineered foods, 
                        and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Genetically Engineered Foods Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) genetically engineered food is rapidly becoming an 
        integral part of the United States and international food 
        supplies;
            (2) the potential positive effects of genetically 
        engineered foods are enormous;
            (3) the potential for negative effects, both anticipated 
        and unexpected, exists with genetic engineering of foods;
            (4) evidence suggests that unapproved genetically 
        engineered foods are entering the food supply;
            (5) it is essential to maintain public confidence in the 
        safety of the food supplies and in the ability of the Federal 
        government to exercise adequate oversight of genetically 
        engineered foods;
            (6) public confidence can best be maintained through 
        careful review of new genetically engineered foods, and 
        monitoring of the positive and negative effects of genetically 
        engineered foods as the foods become integrated into the food 
        supplies, through a review and monitoring process that is 
        scientifically sound, open, and transparent, and that fully 
        involves the general public; and
            (7) since genetically engineered foods are developed 
        worldwide and imported into the United States, it is also 
        imperative to ensure that imported genetically engineered foods 
        are subject to the same level of oversight as domestic 
        genetically engineered foods.

SEC. 3. PREMARKET REVIEW OF GENETICALLY ENGINEERED FOODS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by adding at the end the following:

``SEC. 414. GENETICALLY ENGINEERED FOODS.

    ``(a) Definitions.--In this section:
            ``(1) Genetic engineering.--The term `genetic engineering' 
        means the application of a recombinant DNA technique or a 
        related technology to modify genetic material with a degree of 
        specificity or precision that is not usually available with a 
        conventional breeding technique or another form of genetic 
        modification.
            ``(2) Genetically engineered food.--The term `genetically 
        engineered food' means a food or dietary supplement that--
                    ``(A)(i) is produced in a State; or
                    ``(ii) is offered for import into the United 
                States; and
                    ``(B) is created by genetic engineering.
            ``(3) Producer.--The term `producer', used with respect to 
        a genetically engineered food means a person, company, or other 
        entity that develops, manufactures, imports, or takes other 
        action to introduce into interstate commerce, a genetically 
        engineered food.
            ``(4) Safe.--The term `safe', used with respect to a 
        genetically engineered food, means that the food is considered 
        to be as safe as the appropriate comparable food that is not 
        created by genetic engineering.
    ``(b) Regulations for Genetically Engineered Foods.--
            ``(1) Premarket consultation and approval.--
                    ``(A) In general.--The Secretary shall issue 
                regulations that require a producer of a genetically 
                engineered food, in order to obtain the approval 
                described in subparagraph (B), to use a premarket 
                consultation and approval process described in 
                subparagraph (C).
                    ``(B) Approval.--The regulations shall require the 
                producer to use the process in order to obtain approval 
                to introduce the food into interstate commerce, except 
                in cases where the producer has previously successfully 
                completed the process described in subparagraph (C) or 
                the voluntary premarket consultation process described 
                in paragraph (2).
                    ``(C) Process.--The regulations shall require the 
                producer to use a premarket consultation and approval 
                process that--
                            ``(i) includes the procedures of the 
                        voluntary premarket consultation process 
                        described in paragraph (2); and
                            ``(ii) meets the requirements of this 
                        subsection.
            ``(2) Voluntary premarket consultation process.--The 
        process referred to in paragraph (1)(C)(i) is the voluntary 
        premarket consultation process described in--
                    ``(A) the guidance document entitled `Guidance on 
                Consultation Procedures: Foods Derived From New Plant 
                Varieties', issued in October 1997, by the Office of 
                Premarket Approval of the Center for Food Safety and 
                Applied Nutrition, and the Office of Surveillance and 
                Compliance of the Center for Veterinary Medicine, of 
                the Food and Drug Administration (or any corresponding 
                similar guidance document);
                    ``(B) the statement of policy entitled `Foods 
                Derived From New Plant Varieties', published in the 
                Federal Register on May 29, 1992, 57 Fed. Reg. 22984 
(or any corresponding similar statement of policy); and
                    ``(C) such other documents issued by the 
                Commissioner relating to such process as the Secretary 
                may determine to be appropriate.
            ``(3) Submission and dissemination of materials.--
                    ``(A) Submission.--The regulations shall require 
                that, as part of the consultation and approval process, 
                each producer of a genetically engineered food submit 
                to the Secretary--
                            ``(i) each summary of research, test 
                        results, and other materials that the producer 
                        is required to submit under the process 
                        described in paragraph (2); and
                            ``(ii) a copy of the research, test 
                        results, and other materials.
                    ``(B) Dissemination.--On receipt of a request for 
                the initiation of a consultation and approval process, 
                or on receipt of such summary, research, results, or 
                other materials for a food, the Secretary shall provide 
                public notice regarding the initiation of the process, 
                including making the notice available on the Internet. 
                The Secretary shall make the summaries, research, 
                results, and other materials relating to the food 
                publicly available, including, to the extent 
                practicable, available on the Internet, prior to making 
                any determination under paragraph (4).
                    ``(C) Protection of trade secrets.--The regulations 
                shall ensure that laws in effect on the date of 
                enactment of the Genetically Engineered Foods Act that 
                protect trade secrets apply with respect to the 
                information submitted to the Secretary under 
                subparagraph (A). Such regulations may provide for the 
                submission of sanitized information in appropriate 
                cases, and the dissemination of such sanitized 
                information.
            ``(4) Determinations.--The regulations shall require that, 
        as part of the consultation and approval process for a 
        genetically engineered food, the Secretary shall--
                    ``(A) determine whether the producer of the food 
                has submitted, during the consultation, materials and 
                information that are adequate to enable the Secretary 
                to fully assess the safety of the food, and make a 
                description of the determination publicly available; 
                and
                    ``(B) if the Secretary determines that the producer 
                has submitted adequate materials and information, 
                conduct a review of the materials and information, and, 
                in conducting the review--
                            ``(i) prepare a response that--
                                    ``(I) summarizes the materials and 
                                information;
                                    ``(II) explains the determination; 
                                and
                                    ``(III) contains a finding by the 
                                Secretary that the genetically 
                                engineered food--
                                            ``(aa) is considered to be 
                                        safe and may be introduced into 
                                        interstate commerce;
                                            ``(bb) is considered to be 
                                        conditionally safe and may be 
                                        so introduced if certain stated 
                                        conditions are met; or
                                            ``(cc) is not considered to 
                                        be safe and may not be so 
                                        introduced;
                            ``(ii) make the response publicly 
                        available; and
                            ``(iii) provide an opportunity for the 
                        submission of additional views or data by 
                        interested persons on the response.
            ``(5) Review for cause.--
                    ``(A) Request for additional review.--The 
                regulations shall provide that any person may request 
                that the Secretary conduct an additional review, of the 
                type described in paragraph (4)(B), for a food on the 
                basis of materials and information that were not 
                available during an earlier review described in 
                paragraph (4)(B) or that were not considered during the 
                review.
                    ``(B) Finding for additional review.--The Secretary 
                shall conduct the additional review, on the basis of 
                the materials and information described in subparagraph 
                (A) if the Secretary finds that the materials and 
                information--
                            ``(i) are scientifically credible;
                            ``(ii) represent significant materials and 
                        information that was not available or 
                        considered during the earlier review; and
                            ``(iii) suggest potential negative impacts 
                        relating to the food that were not considered 
                        in the earlier review or demonstrate that the 
                        materials and information considered during the 
                        earlier review were inadequate for the 
                        Secretary to make a safety finding.
                    ``(C) Additional materials and information.--In 
                conducting the additional review, the Secretary may 
                require the producer of the genetically engineered food 
                to provide additional materials and information, as 
                needed to facilitate the review.
                    ``(D) Finding.--In conducting the review, the 
                Secretary shall--
                            ``(i) issue a response described in 
                        paragraph (4)(B) that revises the finding made 
                        in the earlier review with respect to the 
                        safety of the food; or
                            ``(ii) make a determination, and issue an 
                        explanation stating, that no revision to the 
                        finding is needed.
                    ``(E) Action of secretary.--If, based on a review 
                under this paragraph, the Secretary determines that the 
                food involved is not safe, the Secretary may withdraw 
                the approval of the food for introduction into 
                interstate commerce or take other action under this Act 
as the Secretary determines to be appropriate.
            ``(6) Exemptions.--
                    ``(A) Categories of genetically engineered foods.--
                            ``(i) Proposed rule.--The Secretary may 
                        issue a proposed rule that exempts a category 
                        of genetically engineered foods from the 
                        regulations described in paragraph (1) if--
                                    ``(I) the rule contains a narrowly 
                                specified definition of the category;
                                    ``(II) the rule specifies the 
                                particular foods included in the 
                                category;
                                    ``(III) the rule specifies the 
                                particular genes, proteins, and adjunct 
                                technologies (such as use of markers or 
                                promoters) that are involved in the 
                                genetic engineering for the foods 
                                included in the category; and
                                    ``(IV) not less than 10 foods in 
                                the category have been reviewed under 
                                paragraph (4)(B) and found to be safe.
                            ``(ii) Public comment period.--The 
                        Secretary shall provide an opportunity, for not 
                        less than 90 days, for the submission of 
                        comments by interested persons on the proposed 
                        rule.
                            ``(iii) Final rule.--At the end of the 
                        comment period described in clause (ii), the 
                        Secretary shall issue a final rule described in 
                        clause (i).
                    ``(B) Regulated genetically engineered foods.--
                            ``(i) Proposed rule.--The Secretary may 
                        issue a proposed rule that exempts from the 
                        regulations described in paragraph (1) 
                        genetically engineered foods that the Secretary 
                        determines are subject to regulation under 
                        Federal law other than this section, such as 
                        foods from pharmaceutical-producing plants.
                            ``(ii) Public comment period.--The 
                        Secretary shall provide an opportunity, for not 
                        less than 90 days, for the submission of 
                        comments by interested persons on the proposed 
                        rule.
                            ``(iii) Final rule.--At the end of the 
                        comment period described in clause (ii), the 
                        Secretary shall issue a final rule described in 
                        clause (i).
            ``(7) Issuance dates.--The Secretary shall issue proposed 

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